MIAMI--(BUSINESS WIRE)--Makana™ Therapeutics, a global leader in the field of xenotransplantation, was granted an important patent in South Korea that will catalyze xenotransplantation efforts in that country, the company announced today. Makana was granted a similar patent in Europe in 2023.

迈阿密--（商业新闻短讯）--Makana™Therapeutics是异种移植领域的全球领导者，该公司今天宣布，该公司在韩国获得了一项重要专利，将促进该国的异种移植努力。2023年，Makana在欧洲获得了类似的专利。

Makana is working to solve the organ shortage crisis by making genetically-modified pigs for use as organ donors for human recipients. The South Korean patent was granted on Makana’s Triple Knockout pig, or “TKO,” which is a combination of three xenoantigen gene knockouts in the pig that effectively camouflage the cross-species grafts from the human recipient’s immune system..

马卡纳正在努力通过制造转基因猪作为人类受体的器官捐赠者来解决器官短缺危机。韩国专利授予了Makana的三重基因敲除猪，即“TKO”，它是猪中三种异种抗原基因敲除的组合，可有效掩盖人类受体免疫系统的跨物种移植物。。

Makana has demonstrated compelling results in xenotransplantation to date. “Our knockout pigs combined with our advancements in immunosuppression and patient matching have resulted in the longest and most consistent preclinical survival data in the xenotransplantation field,” said Mark Platt, the company’s President and Chief Executive Officer.

迄今为止，Makana在异种移植方面已显示出令人信服的结果。该公司总裁兼首席执行官马克·普拉特（Mark Platt）表示：“我们的基因敲除猪结合我们在免疫抑制和患者匹配方面的进步，在异种移植领域产生了最长和最一致的临床前生存数据。”。

“We are very pleased that the Triple Knockout Pig, which was discovered in the lab of our founder, Dr. Joe Tector, is being adopted as the ‘gold standard’ of baseline genetics for xenotransplantation.”.

“我们非常高兴，在我们的创始人乔·特克托博士的实验室中发现的三基因敲除猪正在被采纳为异种移植基线遗传学的“黄金标准”。”。

On March 21, 2024, Mass General Hospital announced that it had transplanted a genetically modified pig kidney into a patient suffering from End Stage Renal Disease. The procedure was performed under the expanded access pathway or “compassionate use” which allows a single patient to receive an investigational medical product when facing an immediate life-threatening condition.

2024年3月21日，马萨诸塞州综合医院宣布将转基因猪肾移植到患有终末期肾病的患者体内。该程序是在扩大的获取途径或“同情使用”下进行的，该途径允许单个患者在面临直接威胁生命的情况下接受研究性医疗产品。

The pig kidney used in the case contained the baseline TKO genetics along with other modifications. The earlier reported “compassionate use” cases of pig heart xenotransplants at the University of Maryland School of Medicine also incorporated the TKO genetics discovered by Makana. While compassionate use authorizations may help a small number of patients, Makana remains focused on pursuing a clinical trial to help the entire population that suffers from organ failure..

该病例中使用的猪肾包含基线TKO遗传学以及其他修饰。马里兰大学医学院（University of Maryland School of Medicine）早些时候报道的“同情使用”猪心异种移植病例也纳入了马卡纳（Makana）发现的TKO遗传学。虽然同情使用授权可能会帮助少数患者，但马卡纳仍然专注于进行临床试验，以帮助整个患有器官衰竭的人群。。

Platt added, “The Triple Knockout Pig has fundamentally changed the field and has moved xenotransplantation closer to becoming a clinically available reality. The organs from our TKO Pig have been shown to match more than 30% of patients waiting for a kidney transplant, and likely more than 70% of patients can benefit from these organs with available pre-transplant treatment.

Platt补充道：“三基因敲除猪从根本上改变了这一领域，并使异种移植更接近于临床上可用的现实。我们的TKO猪的器官已被证明与超过30%等待肾移植的患者相匹配，并且可能超过70%的患者可以通过可用的移植前治疗从这些器官中受益。

Our team is working tirelessly to reach our goal of allowing every patient suffering from organ failure to return to an entirely normal life.”.

我们的团队正在不懈地努力，以实现我们的目标，让每一位器官衰竭患者恢复完全正常的生活。”。

According to the National Kidney Foundation, there were 786,000 patients in the U.S. living with kidney failure in 2021. In 2022, there were approximately 25,000 kidney transplants performed in the U.S. However there are still an estimated twelve people dying each day in the U.S. while waiting to receive a life-saving kidney transplant.

根据国家肾脏基金会的数据，2021年美国有786000名肾衰竭患者。2022年，美国大约进行了25000例肾脏移植。然而，在美国，每天仍有大约12人在等待接受挽救生命的肾脏移植时死亡。

Currently there are more than 93,000 people on the U.S. kidney transplant waitlist. This has been an enduring challenge for organ transplantation, with the waiting list substantially larger than the supply of donor organs..

目前，美国肾脏移植候补名单上有93000多人。这对器官移植来说是一个持久的挑战，等待名单远远超过了供体器官的供应。。

Makana is in discussions with the U.S. Food and Drug Administration regarding the final steps prior to conducting the first-ever human clinical trial in kidney xenotransplantation. The trial is expected to be conducted at the University of Miami. Dr. Tector, MD, PhD, FACS, a practicing transplant surgeon, heads up the xenotransplant program at the Miami Transplant Institute (MTI), a collaboration between Jackson Memorial Hospital and the University of Miami Health System..

马卡纳正在与美国食品和药物管理局讨论在进行首次异种肾移植人体临床试验之前的最后步骤。该试验预计将在迈阿密大学进行。Tector博士，医学博士，博士，FACS，一位执业移植外科医生，负责迈阿密移植研究所（MTI）的异种移植项目，该研究所是杰克逊纪念医院和迈阿密大学卫生系统之间的合作项目。。

“The TKO pig is widely seen as the preferred genetic profile that will enter clinical trials,” Platt said. “We’ve been diligently driving our work to its clinical stage for more than a decade. We will profoundly improve both the length and quality of life for our patients, beginning with Patient One.”.

普拉特说：“TKO猪被广泛认为是进入临床试验的首选基因谱。”。“十多年来，我们一直在努力将我们的工作推向临床阶段。我们将从患者一开始，深刻改善患者的寿命和生活质量。”。

About Makana Therapeutics

关于Makana Therapeutics

Founded in 2009, Makana Therapeutics is focused on developing swine with reduced xenoantigen expression, making human transplantation of cells, tissues and organs from these animals possible. Makana's focus on simplified genetics, optimized pig cloning techniques and careful patient selection is expected to streamline product development and result in safer more efficacious products.

Makana Therapeutics成立于2009年，专注于开发异种抗原表达减少的猪，使这些动物的细胞，组织和器官的人体移植成为可能。马卡纳专注于简化遗传学，优化猪克隆技术和仔细的患者选择，有望简化产品开发并产生更安全更有效的产品。

For more information on Makana, please visit www.makanatherapeutics.com..

有关Makana的更多信息，请访问www.makanatherapeutics.com。。